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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03455478
Other study ID # YFZX2018001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date November 30, 2026

Study information

Verified date May 2022
Source Shanghai Eye Disease Prevention and Treatment Center
Contact Xun Xu, MD
Phone 8613386259538
Email drxuxun@tom.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Blindness and visual impairment severely impact the visual health and life quality of people, particularly the 2.566 million senior citizens aged at 65 and above in Shanghai. The main reason is uncorrected refractive error, of which, 62.1% can be solved through refractive correction. For this reason, the uncorrected refractive errors of 154,000 senior citizens in Shanghai can be taken as a priority among the public health issues to prevent blindness. Now, with the aim to reduce the prevalence rate of blindness and visual impairment, it is planned to establish a public health service mechanism in terms of refractive error screening and correction for the elderly by relying on Shanghai's three-level (city-district-community) eye diseases prevention network, using proper refractive correction technology, and moving related services forward to communities in order to screen, identity, and correct blindness and visual impairment caused by refractive errors as early as possible.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000000
Est. completion date November 30, 2026
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - shanghai residents aged =18 years old Exclusion Criteria: - cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
spectacles
dispending spectacles for uncorrected refractive error

Locations

Country Name City State
China Shanghai Eye Disease Prevention & Treatment Center Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Eye Disease Prevention and Treatment Center Brien Holden Vision

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary best-corrected visual acuity (BCVA) the prevalence of blindness and visual impairment 5 years
Primary cataract surgery rate cataract surgery rate of Shanghai older people 5 years
Primary cataract surgery coverage rate cataract surgery coverage rate of Shanghai cataract patients 5 years
Primary visual impairment caused by high myopia observing the rate of visual impairment caused by high myopia 5 years